The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study

Inclusion criteria

• Age: 18 to 70.
• Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:

• Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements <3 times per week.
• It is rare to have loose stools without laxatives.
• Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.
• Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.
• Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.

Exclusion criteria

• Pregnancy or lactation.
• Unable to take the intervention product or complete the examination as required.
• Language expression disorder or mental illness.
• Physical examination showed severe liver and kidney dysfunction.
• Acute gastrointestinal disease within 4 weeks.
• Constipation caused by surgery in the past 4 weeks.
• History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging.
• Participation in other clinical trials within 3 months prior to enrollment.
• Other health problems are not suitable for participation in the study.